Questions Regarding "Does The Rule Apply to My Activity?"

• To date, FDA has received over 100,000 inquiries, more than 2/3 of which are questions of applicability

• Please read the rules first - many questions are answered there

• Next, please see our website for Question and Answer (Q&A) documents in which we respond to new questions: http://www.cfsan.fda.gov/~dms/guidance.html